“The decision is intended to assure current and future generic manufacturers that they may manufacture and sell high quality generic versions of SIRTURO without a concern that the Company will enforce its bedaquiline patents, provided the generic versions of SIRTURO® produced or supplied by generic manufacturers are of good quality, medically acceptable, and are used only in the 134 low- and middle-income countries,” J&J said in a statement last week.
The expiry of a patent on Bedaquiline paved the way for generic manufacturers like Lupin and Macleods, among others to initiate supplies soon, ensuring cheaper and wider access to the drug.
J&J had attempted to extend its patent by 4 years in India by filing for a secondary patent. However, in April the patent office in India rejected the secondary patent of the drug, that would have extended the monopoly on key anti Tuberculosis drug- beyond the primary patent that expired in July this year.The company had filed a patent for Fumarate salt of Bedaquiline in 2008 to extend its patent till the end of 2027.
It was under review by the patent office. The strategy is called patent evergreening used by companies to keep the prices high as it would keep the affordably priced generic versions of the drug out of the market.
